The 505(b)(2) approval pathway, designed to expedite reviews, actually takes about five months longer than the standard NDA process, says a new report from the Tufts Center for the Study of Drug Development.
To View This Article:
Subscribe To FDAnews
The trusted source for drug and device insights
Compliance — and business success — are rooted in an understanding of the top pharma, medical device and regulatory developments.
For decades, top drug and device manufacturers have relied on FDAnews’ insightful coverage with two of the industry’s most-trusted publications: Drug Industry Daily and Device Daily Bulletin Premium. These two publicationshave recently merged to become FDAnews, a trusted one-stop destination for drug and device insights. FDAnews delivers what you need to know each business day.
Written and reported by FDAnews’ team of experienced industry journalists and subject matter experts, each issue delivers coverage of the regulatory, legislative and business changes affecting the global drug and device industry.
Each business day, FDAnews provides valuable insights into:
Best practices in regulatory compliance and the pathways to approval
Draft and final guidances from the FDA and other regulatory agencies
Company mergers and technology developments
FDA budgets and spending, including proposals and approvals by Congress and the President
Quality and GMP regulatory policies and developments
FDA inspection policies, practices and enforcement activities
Global enforcement and supply chain trends
Reports and perspective on Form 483s, warning letters, recalls, FDA policy notices and other reports
New features found only in FDAnews:
In-depth exposés that take a deep dive into essential pharmaceutical and device issues
Original columns from thought leaders and former FDA officials on trending topics
Excerpts of best-selling FDAnews webinar and book content
Daily posts of breaking headlines and premium stories throughout the day on fdanews.com
FDAnews delivers precisely what you need to know each business day. It makes sense of everything successful drug and device manufacturers must know and do, delivering the news, analysis and interpretation of industry changes you need to stay in compliance and thrive.
Start your subscription to FDAnews — the trusted source for drug and device insights — today.
Start your single-user one-year subscription (250 issues) FDAnews for only $1,895.
Also available: Take advantage of our multi-user and site licenses of FDAnews, so you’ll have the most-informed workforce! Contact Will Tuttle, Business Development Representative at firstname.lastname@example.org or +1 612.216.2948 to receive a custom quote.